The tariff classification of cardiac catheters from Ireland.

N201383 February 17, 2012 CLA-2-90:OT:RR:NC:N4:405 CATEGORY: Classification TARIFF NO.: 9018.39.0040  John M. Peterson Russell A. Semmel Neville Peterson, LLP Counsellors at Law 17 State Street – 19th Floor New York, New York 10004 RE:      The tariff classification of cardiac catheters from Ireland. Dear Mr. Peterson, and Mr. Semmel: In your letter, dated January 17, 2012, on behalf of Medtronic Inc., you requested a tariff classification ruling. No samples were provided.  Per the copies you supplied of Medtronic’s 510-k submissions to the US Food and Drug Administration: “The Attain Select II 6248DEL Delivery Catheter System contains a delivery catheter and an inner catheter...The SelectSite 304 Deflectable Catheter System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 valve, 1 guidewire, 1 needle and 1 syringe.”  You state, that they are indicated for the delivery of pacing leads, balloon catheters, contrast medium, and other transvenous devices to the coronary sinus and left heart venous anatomy.  You propose classification in either HTSUS 9018.39.0040 or 9021.90.4000.  The Explanatory Notes (ENs), which constitute the official interpretation of the Harmonized Tariff Schedule of the United States (HTSUS) at the international level, state in Note X to Rule 3(b), of the General Rule of Interpretations (GRI), that the term "goods put up in sets for retail sale" means goods which: consist of at least two different articles which are, prima facie, classifiable in different headings; (b) consist of products or articles put up together to meet a particular need and carry out a specific activity; and (c) are put up in a manner suitable for sale directly to users without repacking. We believe the merchandise should be classified in 9018.39.0040, in that each contains either only catheters or the like and is a set, according to GRI 3(b), in which they give the essential character to the whole.   In accordance with the above, the applicable subheading for both items will be 9018.39.0040, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Bougies, catheters (except rubber catheters), drains and sondes, and parts and accessories thereof. The rate of duty will be free.                         Regarding your claim of a secondary classification under HTSUS 9817.00.96 for both items, we are returning your request for a ruling and any related samples, exhibits, etc. We need additional information in order to issue a ruling.  Please submit the information described below: 1. It the first paragraph of your Description of the Merchandise, you discuss their use only with the pacing leads that will carry electrical pulses from implantable cardiac devices and cite ruling that relate only to similar functions.  However, on your page 3, you indicate that both items are “indicated for the delivery of pacing leads, balloon catheters, contrast medium, and other transvenous devices to the coronary sinus and left heart venous anatomy.” a. Is the “contrast medium” a liquid which is used to improve the contrast in diagnostic imaging of the heart and its blood flow?  If so, how is that use not “diagnostic” per HTSUS, Chapter 98, Subchapter 17, U.S. Note 4-b-iii?  b. Explain the use of the balloon catheter in relation to these two items. c. What are the “other transvenous devices”? d. For a, b, and c above, approximately how often is this the use of the imports?   e. What physical features, if any, make these items specially designed for inserting pacing leads as opposed, in particular, injecting a contrast medium? 2. State whether classification advice has been sought from a Customs officer; and if so, from whom, and what advice was rendered, if any. If you decide to resubmit your request, please include all of the material that we have returned to you and mail your request to U.S. Customs and Border Protection, Customs Information Exchange, 10th Floor, One Penn Plaza, New York, NY 10119, attn: Binding Rulings Section. Duty rates are provided for your convenience and are subject to change.  The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported.  If you have any questions regarding the ruling, contact National Import Specialist J. Sheridan at (646) 733-3012. Sincerely, Thomas Russo Director National Commodity Specialist Division